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MVASI is a brand name for Bevacizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between MVASI and the reference biologic drug AVASTIN®. Metastatic Colorectal Cancer (mCRC) - MVASI (bevacizumab for injection), in combination with fluoropyrimidine-based chemotherapy, is indicated for first-line treatment of patients with metastatic…
Verbatim from this product's HC label. Tap a section to expand.
for guidance on dose adjustments. Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) - MVASI, in combination with carboplatin/paclitaxel chemotherapy regimen, is indicated for treatment of patients with unresectable advanced, metastatic or recurrent non- squamous non-small cell lung cancer.
Platinum-sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer - MVASI, in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer.
These patients should not have received prior VEGF- targeted therapy including MVASI. - The effectiveness of bevacizumab in platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer is based on an improvement of progression- free survival in patients who had first recurrence after 6 months of platinum-based chemotherapy.
No overall survival benefit was demonstrated with bevacizumab. Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer - MVASI, in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin, is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens.
These patients should not have received prior VEGF- targeted therapy including MVASI. MVASI® (bevacizumab for injection) Product Monograph Page 5 of 103 - The effectiveness of bevacizumab in platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer is based on a study in patients with disease progression within < 6 months from the most recent platinum-based chemotherapy, with a minimum of 4 platinum therapy cycles completed.
A statistically significant improvement in progression-free survival was seen. No overall survival benefit was demonstrated with bevacizumab. Malignant Glioma (WHO Grade IV) – Glioblastoma - MVASI, in combination with lomustine, is indicated for the treatment of patients with glioblastoma after relapse or disease progression, following prior therapy.
- The efficacy of bevacizumab in relapsed glioblastoma is based on an improvement in progression free survival, while an improvement in overall survival was not demonstrated in study EORTC 26101 (see As with all therapeutic proteins, there is a potential for immunogenicity.
). MVASI® (bevacizumab for injection) Product Monograph Page 6 of 103 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Eye Disorders: Mvasi is not formulated and has not been authorized for intravitreal use.
Local and systemic adverse events have been reported in the post-market setting with unauthorized intravitreal use (see 0 7 WARNINGS AND PRECAUTIONS, General). Gastrointestinal Perforations: Mvasi administration can result in the development of gastrointestinal perforation in some instances resulting in fatality.
Gastrointestinal perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with bevacizumab (ie, was not correlated to duration of exposure). The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting.
Gastrointestinal perforation should be included in the differential diagnosis of patients on Mvasi presenting with abdominal pain. 2%. 7% in platinum-resistant ovarian cancer studies. The incidence of gastrointestinal perforation in patients receiving irinotecan/bolus 5-fluorouracil/leucovorin with bevacizumab was 2%.
Mvasi therapy should be permanently discontinued in patients with gastrointestinal perforation (see 0 7 WARNINGS AND PRECAUTIONS, Gastrointestinal and 0 8 ADVERSE REACTIONS, Gastrointestinal) Wound Healing Complications: Mvasi administration can result in wound dehiscence, in some instances resulting in fatality.
Mvasi therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention. Mvasi should be discontinued at least 28 days prior to elective surgery. Mvasi therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed (see 0 7 WARNINGS AND PRECAUTIONS, Peri-Operative Considerations, Wound Healing).
04 / 2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .......................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................ 4 1 INDICATIONS ................................................................................................................
1 Pediatrics .............................................................................................................. 2 Geriatrics ...............................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................... 6 4 DOSAGE AND ADMINISTRATION ................................................................................
1 Dosing Considerations .......................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 3 Reconstitution .......................................................................................................
4 Administration ....................................................................................................... 9 5 OVERDOSAGE ............................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ...................... 10 7 WARNINGS AND PRECAUTIONS .............................................................................. 1 Special Populations .............................................................................................
Mvasi is contraindicated in patients with known hypersensitivity to: This drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 0 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING, Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
Mvasi is contraindicated in patients with untreated Central Nervous System (CNS) metastases (see 0 7 WARNINGS AND PRECAUTIONS and 0 8 ADVERSE REACTIONS). MVASI® (bevacizumab for injection) Product Monograph Page 6 of 103
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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63%) tested positive for treatment-emergent anti-bevacizumab antibodies detected by an electrochemiluminescent (ECL) based assay. Among these 14 patients, three tested positive for neutralizing antibodies against bevacizumab using an enzyme-linked immunosorbent assay (ELISA).
The clinical significance of these anti-product antibody responses to bevacizumab is unknown. Samples for assessment of human-anti-human antibody (HAHA) were not collected in the platinum-sensitive recurrent ovarian cancer study AVF4095g or in the platinum-resistant ovarian cancer study MO22224.
Immunogenicity assay results are highly dependent on the sensitivity and specificity of the test method and may be influenced by several factors, including sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies to bevacizumab with the incidence of antibodies to other products may be misleading. 4 Clinical Trials – Reference Biologic Drug for information). 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
4 Geriatrics). 2 CONTRAINDICATIONS Mvasi is contraindicated in patients with known hypersensitivity to: This drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 0
Hemorrhage: Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients receiving bevacizumab.
Do not administer Mvasi to patients with serious hemorrhage or recent hemoptysis (see 0 4 DOSAGE AND ADMINISTRATION, 0 7WARNINGS AND PRECAUTIONS, and 0 8 ADVERSE REACTIONS). 1 Dosing Considerations It is recommended that Mvasi treatment be continued until progression of the underlying disease.
There are no recommended dose reductions. Discontinue Mvasi for: Gastrointestinal perforations (gastrointestinal perforations, fistula formation in the gastrointestinal tract, intra-abdominal abscess); MVASI® (bevacizumab for injection) Product Monograph Page 7 of 103 Internal fistula not arising in the GI tract, tracheoesophageal (TE) fistula or any Grade 4 fistula; Wound dehiscence and wound healing complications requiring medical intervention; Necrotizing fasciitis; Serious hemorrhage or recent hemoptysis; Severe arterial thromboembolic events; Life-threatening (Grade 4) venous thromboembolic events (VTEs), including pulmonary embolism; Severe hypertension not controlled with medical management; Hypertensive crisis or hypertensive encephalopathy; Posterior Reversible Encephalopathy Syndrome (PRES); Nephrotic syndrome.
Temporarily suspend Mvasi for: At least 4 weeks prior to elective surgery; Moderate to severe proteinuria pending further evaluation; Severe infusion reactions. 2 Recommended Dose and Dosage Adjustment Metastatic Colorectal Cancer The recommended dose of Mvasi is 5 mg/kg of body weight given once every 14 days as an intravenous infusion.
Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) The recommended dose of Mvasi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion in addition to carboplatin + paclitaxel chemotherapy regimen.
In clinical trials, bevacizumab was administered in addition to carboplatin/paclitaxel chemotherapy for up to 6 cycles of treatment followed by bevacizumab as a single agent until disease progression. Platinum-sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Mvasi is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Mvasi is administered in combination with carboplatin and gemcitabine for 6 cycles and up to 10 cycles followed by continued use of Mvasi as single agent until disease progression. Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer The recommended dose of Mvasi is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion when administered in combination with one of the following agents – MVASI® (bevacizumab for injection) Product Monograph Page 8 of 103 paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin [see As with all therapeutic proteins, there is a potential for immunogenicity.
63%) tested positive for treatment-emergent anti-bevacizumab antibodies detected by an electrochemiluminescent (ECL) based assay. Among these 14 patients, three tested positive for neutralizing antibodies against bevacizumab using an enzyme-linked immunosorbent assay (ELISA).
The clinical significance of these anti-product antibody responses to bevacizumab is unknown. Samples for assessment of human-anti-human antibody (HAHA) were not collected in the platinum-sensitive recurrent ovarian cancer study AVF4095g or in the platinum-resistant ovarian cancer study MO22224.
Immunogenicity assay results are highly dependent on […]
1 Pregnant Women ............................................................................................. 2 Breastfeeding .................................................................................................. 3 Pediatrics.........................................................................................................
4 Geriatrics ......................................................................................................... 19 8 ADVERSE REACTIONS ..............................................................................................
1 Adverse Reaction Overview ................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Reactions ..................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .......................................................................................................... 5 Post-Market Adverse Reactions ..........................................................................
65 MVASI® (bevacizumab for injection) Product Monograph Page 3 of 103 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview .................................................................................
4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions........................................................................................ 6 Drug-Herb Interactions ........................................................................................
7 Drug-Laboratory Test Interactions ....................................................................... 67 10 CLINICAL PHARMACOLOGY ..................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................ 68 11 STORAGE, STABILITY AND DISPOSAL ....................................................................
71 12 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 71 PART II: SCIENTIFIC INFORMATION..................................................................................... 72 13 PHARMACEUTICAL INFORMATION ..........................................................................
72 14 CLINICAL TRIALS ....................................................................................................... 3 Immunogenicity ...............................................................................................
4 Clinical Trials – Reference Biologic Drug ......................................................... 73 15 MICROBIOLOGY ......................................................................................................... 91 16 NON-CLINICAL TOXICOLOGY ...................................................................................
91 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................ 93 PATIENT MEDICATION INFORMATION................................................................................. 94 MVASI® (bevacizumab for injection) Product Monograph Page 4 of 103 MVASI® (bevacizumab for injection) is a biosimilar biologic drug (biosimilar) to AVASTIN®.
PART I:
HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Indications have been granted on the basis of similarity between MVASI and the […]